MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE LI-ION BATTERY¿; SECONDARY BATTERY

Model Number	100
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the autopulse platform (sn(b)(6) failed during a cardiac arrest.Per the reporter, the device did not display any user advisories before it stopped delivering compressions.According to the crew, the autopulse platform just shut off after around 6 minutes when was used with the autopulse li-ion battery (sn (b)(6).Per the customer, the battery was fully charged before use during the patient event.A second fully charged autopulse li-ion battery (sn unknown) was installed but the device still failed to deliver compressions.The patient was on the living room floor; the type and condition of the flooring surface were not specified.In addition, it was noted that the lifeband was rubbing the plastic enclosure of the platform and causing damage to the lifeband as well.Manual cpr was continued until the crew deployed a second autopulse platform (sn unknown).However, it failed as well due to a lifeband alignment issue that could not be resolved.The crew did manual cpr throughout the rest of the event.No impact or consequence to the patient.After the call, back at the station, the second platform (sn unknown) was tested after the driveshaft was realigned and the device functioned as intended.
Additional Manufacturer Narrative
Zoll has not received the autopulse li-ion battery for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.
Additional Manufacturer Narrative
The reported complaint of the autopulse li-ion battery (sn (b)(6) powered off the autopulse platform after 6 minutes was not confirmed during the functional testing and the archive data review.No device malfunction was observed during the testing, and the battery worked as intended.The archive data review showed no errors recorded around the customer's complaint date.The battery was last charged successfully on february 20, 2025, and had 57 successful charge cycles over the battery lifetime.The battery passed charging in a known good autopulse multi-chemistry battery charger, and the status leds of the battery showed four solid green lights after the successful charging attempt.The battery was able to power the autopulse platform for 50 minutes until discharged without any fault or error.

• Brand Name: AUTOPULSE LI-ION BATTERY¿
• Common Device Name: SECONDARY BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 21370651
• Report Number: 3010617000-2025-00145
• Device Sequence Number: 20973444
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown